Wrongful Death Attorney Comments on Lawsuit Claiming Drug Caused Brain Hemorrhage
Chicago, IL (Law Firm Newswire) May 8, 2013 – A wrongful death lawsuit has been filed claiming that the drug Pradaxa caused a fatal brain hemorrhage.
The plaintiff, Martha Lesnick, claims that her husband started taking Pradaxa in January of 2011 as part of a blood-thinning treatment and suffered massive bleeding in his brain two months later, which led to his death. The lawsuit joins ongoing multi-district litigation (MDL) in Illinois federal court.
“In this case, the plaintiff alleges that the drug manufacturer failed to adequately warn her husband and his doctor of the risk of bleeding,” said Paul Greenberg, a Chicago wrongful death attorney, who is not involved in the litigation.
According to the lawsuit, both the patient, Robert Lesnick, and his doctor, were unaware of the risk of uncontrolled bleeding. The federal Food and Drug Administration (FDA) approved Pradaxa in October of 2010 to prevent stroke and blood clots in patients with atrial fibrillation. Since then, patients have reported uncontrolled bleeding, but the drug's manufacturer, Boehringer Ingelheim, allegedly failed to warn patients of the risk. The complaint alleges that the manufacturer spent hundreds of millions of dollars marketing the medication to primary care physicians and cardiologists through visits by sales staff, and marketing the drug directly to consumers through advertisements.
Pradaxa has been marketed as a safe alternative to the anticoagulant Warfarin, without the necessity of change in diet and constant monitoring required when taking Warfarin. With any anticoagulant, there is a risk of bleeding. If patients taking Warfarin begin bleeding, vitamin K can reverse the effects. However, there is not currently a similar reversal agent for patients who begin bleeding while taking Pradaxa. According to the lawsuit, Boehringer Ingelheim did not adequately warn doctors of the irreversibility of the anticoagulant effect.
The FDA had received approximately 500 reports of U.S. deaths linked to Pradaxa by December of 2011, and the complaint alleges that in a six-month period during 2010-2011 there were 932 Serious Adverse Event reports regarding Pradaxa filed with the FDA.
A large portion of the more than 250 lawsuits regarding Pradaxa have been consolidated in MDL in the U.S. District Court for the Southern District of Illinois, to prevent duplication of discovery and conflicting rulings. Lesnick's lawsuit seeks damages in excess of $75,000 and claims causes of action including negligence, failure to warn and fraudulent concealment.
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